St Joseph Dermatopathology

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and (re)certification is recommended. Standard level deficiencies were cited. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a review of the laboratory's testing records, the laboratory's twice annual accuracy assessment records, and staff interview, the laboratory failed to have documentation of performing the following accuracy assessments in 2023 and 2024: a) two of two assessments for Mineral Oil Preparations b) two of two assessments for Tzank smears. Findings include: 1. A review of the laboratory's testing records revealed the laboratory performed the following tests: - Histopathology slide interpretations - KOH Preparations - Mineral Oil Preparations - Tzank Smears 2. A review of the laboratory's twice annual accuracy assessment records for 2023 and 2024 revealed the laboratory failed to have documentation of performing twice annual accuracy assessments for Mineral Oil Preparations and Tzank Smears. 3. In an interview on 2/12/25 at 9:50 a.m. in the office, after review of the records, the manager confirmed the above findings. ***NOTE- This is a repeat deficiency from the survey performed on 2/27/23.*** Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions in the CLIA program, and recertification is recommended. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a review of the laboratory's testing records, the laboratory's twice annual accuracy assessment records for 2022 and staff interview, it was revealed that the laboratory failed to have documentation of performing the following accuracy assessments in 2022: a) one of two assessments for Mineral Oil Preparations. b) two of two assessments for Tzank smears. Findings include: 1. A review of the laboratory's testing records revealed the laboratory performed the following tests: - Histopathology slide interpretations - KOH Preparations - Mineral Oil Preparations - Tzank Smears 2. A review of the laboratory's twice annual accuracy assessment records for 2022 revealed the laboratory performed assessments on the following dates in 2022: Histopathology slide interpretations: 1/23/22 and 5/15/22 KOH: 9/19 /22 and 10/26/22 Mineral Oil Preparations: 9/7/22 3. Further review of the accuracy assessment records revealed the laboratory failed to have documentation of performing a second assessment for the Mineral Oil Preparations and two assessments for the Tzank Smears in 2022. 4. An interview with the manger on 2/27/23 at 9:57 a. m. in the office, after her review of the records, confirmed the above findings. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --